FDA recall Z-1250-2019

Product

Fetal Spiral Electrode, Model No. 9898 031 37631

Reason for recall

During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.

Distribution

Distributed nationwide within US. Worldwide international distribution.

Key facts

Status

Terminated

Initiation date

2019-01-25

Report date

2019-05-08

Termination date

2020-12-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2019